BrioHealth Solutions enroled its first patients in the U.S. for the INNOVATE trial of its BrioVAD system. Burlington, Massachusetts–based BrioHealth has had its BrioVAD technology under development since 2008. The left ventricular assist device (LVAD) features the BrioVAD pump, a fully magnetically suspended blood pump. It pairs with uniquely engineered external components aimed at reducing adverse events and enhancing patient quality of life.
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BrioVAD’s magnetic bearing design achieves a smaller pump size with a larger impeller compared to Abbott’s HeartMate 3, the only FDA-approved durable ventricular assist system currently available, BrioHealth said in a news release. The compact pump may reduce surgical invasiveness with its size.
Additionally, the pump incorporates a novel driveline design that electrically connects it to external components. This enables a thinner, more flexible driveline which could reduce driveline-associated infections. An advanced flow pump design could also improve hemocompatibility and hemodynamics, minimizing the risk of serious complications.
More than 350 patients outside the U.S. have been treated with a ventricular assist system that incorporates the BrioVAD pump. The INNOVATE trial evaluates the safety and effectiveness of BrioVAD in treating advanced, refractory left ventricular heart failure.
“We are thrilled to kick off the INNOVATE trial, following a phenomenal journey of innovation, engineering, and quality refinement to bring the BrioVAD system to life,” said Chen Chen,Ph.D., CEO of BrioHealth Solutions. “Despite advancements in ventricular assist devices, there remains a pressing need for improved device performance and patient outcomes, and BrioHealth is committed to addressing this gap. It is also incredibly rewarding to see the enthusiasm from our participating centers in advancing heart failure treatment through this study.”
